BEUDAMED
    FDA Recall Terminated

    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

    Recall: Z-1837-2017 · Initiated March 27, 2017

    Recall

    Recall Number
    Z-1837-2017
    Event Number
    76855
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    PAX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2017
    Terminated
    December 5, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

    Reason

    Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.

    Action

    Alcon sent an Urgent Voluntary Medical Device Recall letters dated March 23, 2017 to customers. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignees to quarantine and return any unused products of the items/lots listed in the letter. For questions contact Customer Service at 1-800-862-5266.

    Distribution

    US Nationwide Distribution

    Quantity

    561,702